Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day

NCT00700271 | Completed Phase 4 Results

• 1 other identifier: CVAA489AFR01
• Study Type: interventional
• Target: 478
• Locations: 2 countries
• Sites: 2

Brief Summary

This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.

Conditions

Hypertension

Keywords

Hypertension; ambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring

  Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment\*country and treatment\*up-titration interactions in case statistically significant at a 0.10 level.

  Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

Secondary Outcomes (10)

• Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

  Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

• Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

  Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

• Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

  Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

• Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring

  Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

• Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure

  Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)

Study Arms (2)

Morning Intake

EXPERIMENTAL

After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg or msSBP \>= 130 mmHg and/or msDBP \>= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP \< 140 mmHg and msDBP \< 90 mmHg or msSBP \< 130 mmHg and msDBP \< 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.

Drug: Amlodipine; Drug: Valsartan

Evening Intake

EXPERIMENTAL

After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg or msSBP \>= 130 mmHg and/or msDBP \>= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP \< 140 mmHg and msDBP \< 90 mmHg or msSBP \< 130 mmHg and msDBP \< 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.

Drug: Amlodipine; Drug: Valsartan

Interventions

Amlodipine DRUG

5 mg or 10 mg tablets.

Evening Intake; Morning Intake

Valsartan DRUG

160 mg capsules.

Evening Intake; Morning Intake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Essential uncontrolled or naive hypertensive patients (SBP ≥= 140 mmHG, DBP - \>/=90 mm Hg, or SBP \>= 130 mmHg, DBP \>= 80 mmHg if diabetes or renal impairment) except patients treated with amlodipine, or intolerant of ARBs and/or calcium channel blockers.

You may not qualify if:

• Severe hypertension : SBP \>= 180 mmHg, DBP \>= 110mmHg
• Pregnancy
• Allergia to ARBs and/or to calcium channel blockers
• Antihypertensive tritherapy at V1
• History of heart failure, pectoris angina, stroke, myocardial infarction
• Diabetes type I
• Renal impairment

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Investigative sites in France

Paris, France

Location

Investigative sites in Tunisia

Tunisia, Tunisia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Roland Asmar

  principle investigator; Institut cardiovasculaire 75016 Paris

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: June 18, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 19, 2011
• Results First Posted: January 6, 2011

Record last verified: 2011-05

Locations

FR (1); TU (1)